Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices 87431 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0795] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; A Survey on 

Quantitative Claims in Direct-toConsumer Prescription Drug 

Advertising 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 17, 

2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The title 

of this information collection is ‘‘A 

Survey on Quantitative Claims in 

Direct-to-Consumer Prescription Drug 

Advertising.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

A Survey on Quantitative Claims in 

Direct-to-Consumer Prescription Drug 

Advertising 

OMB Control Number 0910–NEW 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes FDA to conduct 

research relating to health information. 

Section 1003(d)(2)(C) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 393(d)(2)(C)) authorizes 

FDA to conduct research relating to 

drugs and other FDA-regulated products 

in carrying out the provisions of the 

FD&C Act. 

The mission of the Office of 

Prescription Drug Promotion (OPDP) is 

to protect the public health by helping 

to ensure that prescription drug 

promotion is truthful, balanced, and 

accurately communicated so that 

patients and healthcare providers can 

make informed decisions about 

treatment options. OPDP’s research 

program provides scientific evidence to 

help ensure that our policies related to 

prescription drug promotion will have 

the greatest benefit to public health. 

Toward that end, we have consistently 

conducted research to evaluate the 

aspects of prescription drug promotion 

that are most central to our mission, 

focusing in particular on three main 

topic areas: advertising features, 

including content and format; target 

populations; and research quality. 

Through the evaluation of advertising 

features, we assess how elements such 

as graphics, format, and the 

characteristics of the disease and 

product impact the communication and 

understanding of prescription drug risks 

and benefits. Focusing on target 

populations allows us to evaluate how 

understanding of prescription drug risks 

and benefits may vary as a function of 

audience. Our focus on research quality 

aims at maximizing the quality of our 

research data through analytical 

methodology development and 

investigation of sampling and response 

issues. This study will inform the first 

topic area, advertising features. 

Because we recognize that the 

strength of data and the confidence in 

the robust nature of the findings are 

improved through the results of 

multiple converging studies, we 

continue to develop evidence to inform 

our thinking. We evaluate the results 

from our studies within the broader 

context of research and findings from 

other sources, and this larger body of 

knowledge collectively informs our 

policies as well as our research program. 

Our research is documented on our 

homepage at https://www.fda.gov/ 

about-fda/center-drug-evaluation-andresearch-cder/office-prescription-drugpromotion-opdp-research, which 

includes links to the latest Federal 

Register notices and peer-reviewed 

publications produced by our office. 

Direct-to-consumer (DTC) 

prescription drug advertising may make 

quantitative claims about the drug’s 

efficacy or risks (Ref. 1). Although there 

is research and FDA guidance 

(‘‘Presenting Quantitative Efficacy and 

Risk Information in Direct-to-Consumer 

Promotional Labeling and 

Advertisements,’’ available at https://

www.fda.gov/media/169803/download) 

that provides general guidelines for how 

to present quantitative information, it is 

not fully understood how consumers 

will interpret specific quantitative 

claims. We conducted a literature 

review and found that while some types 

of quantitative information are wellstudied (e.g., relative frequencies), many 

questions remain on how best to 

communicate certain quantitative 

information about prescription drugs. 

For example, we do not have sufficient 

information about how consumers 

interpret different claims describing 

medians (e.g., ‘‘People treated with Drug 

X lived for a median of 8 months’’ alone 

or in combination with a definition such 

as ‘‘In people receiving Drug X, this 

means that about half lived more than 

8 months and about half lived less than 

8 months’’ or ‘‘A median is the middle 

number in a group of numbers ordered 

from smallest to largest’’). This study 

aims to survey U.S. adults about their 

interpretation of specific quantitative 

claims. 

We plan to use an address-based, 

mixed-mode methodology that will 

direct one randomly chosen member of 

sampled households to complete a 20- 

minute online survey, with 

nonrespondents receiving a paper 

questionnaire. The sample will be 

representative of the U.S. population. A 

sample of U.S. households will be 

drawn from the U.S. Postal Service 

Computerized Delivery Sequence File. 

Adults aged 18 or over will be eligible 

for participation. Up to four contacts 

(mailings) will be sent to respondents by 

U.S. mail. The contacts will include the 

URL for the online survey and a unique 

survey login. This unique survey login 

will be used to track completed surveys 

without the use of personally 

identifying information. The contact 

method, based on recent 

recommendations (Ref. 2), includes a 

prenotification letter (week 1), a web 

survey invitation letter (soft launch in 

week 2, full launch in week 3), a 

reminder postcard sent to 

nonresponders (week 5), and a final 

mailing with the paper version of the 

survey sent to nonresponders (Week 7). 

We estimate a 40-percent response rate, 

based on recent experience with similar 

surveys. We estimate 1,100 respondents 

will complete the main study (see table 

1). 

Based on previous research (Refs. 3, 4, 

and 5), we plan to include a small 

prepaid incentive in the second mailing 

sent to the sampled addresses as a 

gesture to encourage response and 

maintain data quality. We expect that 


khammond on DSKJM1Z7X2PROD with NOTICES
87432 Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices 

approximately 5 percent of the sampled 

addresses will be postal non-deliverable 

returned letters from the first mailing 

(prenotification letter), so the second 

mailing is estimated to go out to the 

remaining addresses. We also will 

conduct an experiment to assess the 

efficacy of using a promised post-paid 

incentive. Seventy-five percent of the 

sample will be sent the promised 

incentive upon completion of the 

survey, and the remaining 25 percent of 

the sample will not be notified of or 

provided with any promised incentive. 

We opted to split the sample 75–25 

rather than 50–50 because the initial 

evidence shows the benefits of 

including a promised incentive (Refs. 4, 

6, and 7), and we aimed to maximize 

response rates. 

The survey contains questions about 

respondents’ perceptions and 

understanding of several quantitative 

claims drawn from DTC ads in the 

marketplace. We will also measure other 

potentially important variables, such as 

demographics and numeracy. The 

survey questions will be informed by 

consumer feedback elicited in one-onone interviews (approved under OMB 

Control No. 0910–0847). The survey is 

available upon request from 

DTCResearch@fda.hhs.gov. 

We will test whether any variables 

differed between modes (online versus 

mail survey) and will account for any 

mode effects in our analyses. We will 

examine the descriptive statistics for the 

survey items (e.g., frequencies and 

percentages) and explore the 

relationship between the survey items 

and demographic and health 

characteristics. We will weigh the data 

to account for different probability of 

selection and nonresponse. 

In the Federal Register of April 25, 

2023 (88 FR 24997), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received two 

submissions that were Paperwork 

Reduction Act (PRA) related. Within the 

submissions, FDA received multiple 

comments that the Agency has 

addressed in this notice. For brevity, 

some public comments are paraphrased 

and, therefore, may not state the exact 

language used by the commenter. All 

comments were considered even if not 

fully captured by our paraphrasing in 

this document. Comments and 

responses are numbered here for 

organizational purposes only. 

(Comment 1) One comment suggested 

testing claims that are addressed by the 

guidance for industry entitled ‘‘Medical 

Product Communications That Are 

Consistent With the FDA-Required 

Labeling—Questions and Answers.’’ 

(Response 1) The focus of this study 

is not to test such claims. In addition, 

because these drugs are fictional, there 

is no label with which to compare the 

claims, which means that the guidance 

is not an applicable concept in this 

study. These study results could apply 

to any quantitative claims similar to 

those we will test. 

(Comment 2) One comment suggested 

recruiting a sufficient number of 

individuals with a health condition or 

their caregivers because they may be 

more familiar with the quantitative 

information in the claims than the 

general population would be. 

(Response 2) Our intent is to conduct 

a nationally representative sample to get 

a broad sense of how the public 

interprets quantitative claims that 

appear in prescription drug ads across 

drug classes. Moreover, the claims we 

are testing refer to several medical 

conditions (i.e., colon cancer, arthritis, 

seizures, migraine, lung cancer, heart 

attack or stroke, eczema), which makes 

it impractical to recruit a sufficient 

number of patients and caregivers for 

each medical condition. However, in 

response to this comment, we have 

added an item to the survey to assess 

whether participants have these 

conditions or have cared for someone 

with these conditions. This will allow 

us to explore associations between 

survey responses and experiences with 

the medical conditions. 

(Comment 3) One comment 

recommended determining participants’ 

comprehension of information regarding 

relative risk, absolute risk, relative 

benefit, and absolute benefit. 

(Response 3) There is a body of 

research on many of these topics; see, 

for example, the references section in 

the guidance for industry entitled 

‘‘Presenting Quantitative Efficacy and 

Risk Information in Direct-to-Consumer 

(DTC) Promotional Labeling and 

Advertisements,’’ available at https://

www.fda.gov/media/169803/download. 

In this survey, we will examine 

participants’ interpretations of relative 

benefit. 

(Comment 4) One comment requested 

information on the number of and 

demographic diversity of the one-on-one 

interviews. 

(Response 4) Since the 60-day Federal 

Register notice was published, we 

conducted 24 interviews (approved 

under OMB Control No. 0910–0847). We 

recruited with demographic diversity in 

mind. Half (50 percent) of the 

participants had some college or more 

education, and half (50 percent) had less 

education. Overall, 58 percent of the 

participants were women, 29 percent 

were non-Hispanic White, 29 percent 

were non-Hispanic Black, and 25 

percent were Hispanic. We also 

recruited participants of different ages: 

42 percent were between the ages of 18 

and 39, 29 percent were between the 

ages of 40 and 59, and 29 percent were 

60 and older. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Read prenotification letter ........................................... 2,993 1 2,993 0.08 (5 min.) .......... 239 

Read web survey invitation letter 2 .............................. 2,843 1 2,843 0.08 (5 min.) .......... 227 

Read reminder postcard .............................................. 2,585 1 2,585 0.03 (2 min.) .......... 78 

Respond to survey (web and paper) ........................... 1,100 1 1,100 0.33 (20 min.) ........ 363 

Total ...................................................................... ........................ ........................ ........................ ................................ 907 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2The numbers assume around 5 percent postal non-deliverables from the prenotification letter and estimates nonrespondents for the subsequent mailings. 

References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff, (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https:// 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices 87433 

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. 

Although FDA verified the website 

addresses in this document, please note 

that websites are subject to change over 

time. 

*1. Sullivan, H.W., K.J. Aikin, and L.B. 

Squiers, ‘‘Quantitative Information on 

Oncology Prescription Drug websites,’’ 

Journal of Cancer Education, vol. 33, 

Issue 2, pp. 371–374, 2018. (https://

www.ncbi.nlm.nih.gov/pmc/articles/

PMC5334459) 

2. Dillman, D.A., J.D. Smyth, and L.M. 

Christian, internet, Phone, Mail, and 

Mixed-Mode Surveys: The Tailored 

Design Method, 4th ed., John Wiley & 

Sons, Inc.: Hoboken, NJ, 2014. 

*3. Cheung, Y.T.D., X. Weng, M.P. Wang, et 

al., ‘‘Effect of Prepaid and Promised 

Financial Incentive on Follow-Up 

Survey Response in Cigarette Smokers: A 

Randomized Controlled Trial,’’ BMC 

Medical Research Methodology, vol. 19, 

Article 138, 2019. (https://link.

springer.com/article/10.1186/s12874- 

019-0786-9) 

4. Mercer, A., A. Caporaso, D. Cantor, et al., 

‘‘How Much Gets You How Much? 

Monetary Incentives and Response Rates 

in Household Surveys,’’ Public Opinion 

Quarterly, vol. 79, pp. 105–129, 2015. 

5. Sun, H., J. Newsome, J. McNulty, et al., 

‘‘What Works, What Doesn’t? Three 

Studies Designed to Improve Survey 

Response,’’ Field Methods, vol. 32, Issue 

3, pp. 235–252, 2020. (https://doi.org/ 

10.1177/1525822X20915464) 

6. Ellis, J., J. Charbonnier, C. Lowenstein, et 

al., ‘‘Assessing the Impacts of Different 

Incentives and Use of Postal Mail on 

Response Rates,’’ American Association 

for Public Opinion Research (AAPOR) 

Conference, Chicago, IL, 2022, May. 

*7. Yu, S., H.E. Alper, A.M. Nguyen, et al., 

‘‘The Effectiveness of a Monetary 

Incentive Offer on Survey Response 

Rates and Response Completeness in a 

Longitudinal Study,’’ BMC Medical 

Research Methodology, vol. 17, Article 

77, 2017. (https://bmcmedresmethodol.

biomedcentral.com/articles/10.1186/ 

s12874-017-0353-1) 

Dated: December 12, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27652 Filed 12–15–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5323] 

Hoffmann-La Roche, Inc., et al.; 

Withdrawal of Approval of Two New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

withdrawing approval of two new drug 

applications (NDAs) from multiple 

applicants. The applicants notified the 

Agency in writing that the drug 

products were no longer marketed and 

requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of 

January 17, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process in 

§ 314.150(c) (21 CFR 314.150(c)). The 

applicants have also, by their requests, 

waived their opportunity for a hearing. 

Withdrawal of approval of an 

application under § 314.150(c) is 

without prejudice to refiling. 

Application No. Drug Applicant 

NDA 021455 ...... Boniva (ibandronate sodium) Tablets, equivalent to (EQ) 2.5 

milligrams (mg) base and EQ 150 mg base.

Hoffmann-La Roche, Inc. c/o Genentech, Inc., 1 DNA Way, 

South San Francisco, CA 94080–4990. 

NDA 022424 ...... Flowtuss (guaifenesin 200 mg/5 milliliters (mL) and 

hydrocodone bitartrate 2.5 mg/5 mL) Oral Solution.

Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY 

10920. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of January 17, 

2024. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms 

inadvertently missing from the table. 

Introduction or delivery for introduction 

into interstate commerce of products 

listed in the table without an approved 

NDA violates sections 505(a) and 301(d) 

of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355(a) and 331(d)). Drug 

products that are listed in the table that 

are in inventory on January 17, 2024 

may continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: December 12, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27661 Filed 12–15–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–3740] 

Priority Zoonotic Animal Drug 

Designation and Review Process; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry (GFI) #283 

entitled ‘‘Priority Zoonotic Animal Drug 

Designation and Review Process.’’ This 

draft guidance is intended to assist 

sponsors pursuing priority zoonotic 

animal drug (PZAD) designation for a 

new animal drug. This draft guidance is 

intended to provide the eligibility 

criteria for PZAD designation, the 

process for requesting PZAD 

designation, and enhancements in the 

FDA review process for PZADs. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 16, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 


khammond on DSKJM1Z7X2PROD with NOTICES